SOLAR & ATRILAZE Atrial Fibrillation Trial (SAAF-T)
Recruitment status was: Not yet recruiting
The purpose of study is to conduct a pivotal evaluation of the EndoPhotonix™ SOLAR™ System and ATRILAZE™ System in order to obtain a labeling claim on the devices for the treatment of atrial fibrillation.
The study will test the safety and effectiveness of the EndoPhotonix™ Laser Ablation Systems to photocoagulate cardiac tissue during cardiac surgery, to create electrical isolation of the pulmonary veins and create other electrical isolation lesions in order to treat atrial fibrillation. The surgical procedure will be conducted during concomitant mitral valve repair or replacement surgery or in combination with other cardiac surgery including aortic valve surgery, tricuspid valve surgery, or coronary artery bypass surgery.
|Atrial Fibrillation||Device: Laser MAZE by Ablation of Cardiac Tissue||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Atrial Fibrillation Treatment Using Laser Ablation of Cardiac Tissue During Concomitant Cardiac Surgery|
- Freedom from atrial fibrillation by 24-hour 3-lead Holter Monitor at the 180 day evaluation. On or Off Class 1 and III anti-arrhythmic medication [ Time Frame: 180 days ]
- Acute SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage [ Time Frame: 0 through 30 days or length of stay ]
- SAE: Death, mediastinitis, myocardial infarction, stroke, transient ischemic attack (TIA), pulmonary embolism, peripheral arterial embolism, esophageal injury, pulmonary vein stenosis; phrenic nerve damage [ Time Frame: 180 days ]
- Determine binary freedom from AF, independent of anti-arrhythmic status as documented by 24 hour 3-Lead Holter Monitor. Reduction of AF burden with assumption of 100% initial burden. To establish improvement in Quality of Life. [ Time Frame: 180 days ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Experimental: Persistent AF
Treatment arm to be compared with historical control.
Device: Laser MAZE by Ablation of Cardiac Tissue
The protocol calls for the creation of the pulmonary vein isolation lesion through the use of the SOLAR™. The additional lesions are to be created using the ATRILAZE™. At surgeon discretion, the ganglia may be ablated and left and right atrial appendages may be removed.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00734058
|Contact: Kirk S. Honouremail@example.com|
|Contact: Cory H. Whitefirstname.lastname@example.org|
|Study Chair:||Kirk S. Honour||EndoPhotonix, Inc.|